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YY/T 1695-2020

Chinese Standard: 'YY/T 1695-2020'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 1695-2020English239 Add to Cart Days<=3 Medical devices for human assisted reproductive technology--Determination of amino acids in human assisted reproductive media Valid YY/T 1695-2020
YY/T 1695-2020Chinese17 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YYT1695-2020 (YYT1695-2020)
Description (Translated English) Medical devices for human assisted reproductive technology--Determination of amino acids in human assisted reproductive media
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C30
Classification of International Standard 11.040.30
Word Count Estimation 12,164
Date of Issue 2020-03-31
Date of Implementation 2021-04-01
Drafting Organization China Institute of Food and Drug test
Administrative Organization China Institute of Food and Drug test
Regulation (derived from) Announcement No. 48 of 2020 by the State Administration of Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY/T 1695-2020
Medical devices for human assisted reproductive technology--Determination of amino acids in human assisted reproductive media
ICS 11.040.30
C30
People's Republic of China Pharmaceutical Industry Standard
Medical devices for human assisted reproductive technology
Method for detecting amino acid in culture solution
2020-03-31 release
2021-04-01 Implementation
Issued by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the China Food and Drug Administration.
This standard was drafted by. China Food and Drug Administration.
The main drafters of this standard. Ke Linnan, Huang Yuanli, Zhao Danmei, Fang Yu, Han Qianqian, Wang Chunren, Duan Xiaojie.
Medical devices for human assisted reproductive technology
Method for detecting amino acid in culture solution
1 Scope
This standard specifies the amino acid analyzer method, high performance liquid chromatography tandem triple quadrupole mass spectrometry method, and high performance liquid chromatography pre-column derivatization
Method to detect the amino acid composition in the culture solution for human assisted reproductive technology.
This standard applies to glycine (GLY), leucine (LEU), and methionine contained in culture fluids for human assisted reproductive technology
(MET), Tyrosine (TYR), Histidine (HIS), Threonine (THR), Alanine (ALA), Isoleucine (ILE), Tryptophan
(TRY), cystine (CYS), lysine (LYS), aspartic acid (ASP), valine (VAL), phenylalanine (PHE), proline
(PRO), serine (SER), glutamic acid (GLU), arginine (ARG), taurine (TAU) quantitative analysis of 19 amino acids.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
GB/T 6682 Analysis laboratory water specifications and test methods
JJG1064-2011 Verification Regulation of Amino Acid Analyzer
YY/T 0995 Terms and definitions of medical devices for human assisted reproductive technology
3 Terms and definitions
The terms and definitions defined in YY/T 0995 and the following apply to this document.
3.1
Aminoacidanalyzer
The ion exchange chromatography column in the amino acid analyzer separates the different amino acids in the sample, and derivatizes with ninhydrin as the column.
Measured at 570nm and 440nm wavelengths, quantified by external standard method.
3.2
High performance liquid chromatography tandem triple quadrupole mass spectrometry high-performanceliquidchromatographycoupledtotan-
demmassspectrometry
High performance liquid chromatography preliminarily separates the components to be tested in the sample, and the triple quadrupole mass spectrometer passes the separated components
The ion-mass-nucleus ratio obtains the ions to be measured, and the ions to be tested are broken into product ions after collision, and finally the quantification of the ions to be measured by the product ion
ingredient.
3.3
High-performance liquid chromatography pre-column derivatization and high-performance liquid chromatography
analysismethod
The component to be tested is first converted into a derivatized product through a derivatization reaction, and then separated from other components in the sample
Quantification by external standard method.
Related standard:   YY/T 1686-2020  YY/T 1686-2020
Related PDF sample:   YY/T 1681-2019  YY/T 1630-2018
   
 
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